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Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. Calcigen™ PSI bone graft substitute can be combined with autogeneous bone marrow aspirate or autogenous blood. Calcigen™ PSI resorbs and is replaced with bone during the healing process.

Calcigen™ PSI bone graft substitute is a resorbable osteoconductive scaffold composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). The device is available as granules, cubes, or cylinders. Calcigen™ PSI is porous with multidirectional interconnected pores resembling that of cancellous bone.

The provided text describes the 510(k) summary for the Calcigen™ PSI Bone Graft Substitute. Based on the information provided, here's a breakdown of the requested details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This indicates that no clinical studies (and therefore no test set) were conducted with the Calcigen™ PSI device itself for this 510(k) submission. Substantial equivalence was claimed based on comparison to legally marketed predicate devices and non-clinical testing/literature review.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no clinical testing was performed for the Calcigen™ PSI device in this submission, there was no test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing and test set were used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or referenced for this 510(k) submission. The document states "Clinical Testing: None provided as a basis for substantial equivalence."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a bone graft substitute, not an algorithm, and its performance is not assessed in a standalone algorithmic manner.

7. Type of Ground Truth Used

For the Calcigen™ PSI device itself, no specific "ground truth" was established via clinical studies for this 510(k). Instead, the substantial equivalence relied on:

• Comparison of technological characteristics (materials, design, indications) to legally marketed predicate devices.
• Non-clinical laboratory testing and literature review, which would implicitly draw on established scientific understanding and historical data regarding bone graft substitutes.

8. Sample Size for the Training Set

Not applicable. This document pertains to a medical device (bone graft substitute), not an AI/algorithm-based device that would require a 'training set'.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of medical device.

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Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. Calcigen™ PSI resorbs and is replaced with bone during the healing process.

Calcigen™ PSI bone graft substitute is a resorbable osteoconductive scaffold composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). The device is available as granules, cubes, or cylinders. Calcigen™ PSI is porous with multidirectional interconnected pores resembling that of cancellous bone. Calcigen™ PSI is supplied sterile for single patient, one time use only.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for a bone graft substitute called Calcigen™ PSI.

It describes:

• The device (Calcigen™ PSI bone graft substitute)
• Its intended use (filling bony voids or gaps)
• Its composition (60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP))
• Its substantial equivalence to other legally marketed predicate devices.

The FDA clearance is based on the device being "substantially equivalent" to predicate devices, implying similar performance and safety characteristics. However, there are no specific numerical acceptance criteria or a study with performance metrics presented in this document. The clearance letter confirms that the device can be marketed based on this substantial equivalence determination, not based on meeting specific, predefined performance criteria from a clinical or analytical study.

Ask a specific question about this device